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Urodynamic Evaluation of Disobstrucitve Power of Aquablation VS Laser Techniques

NCT03846700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-20

No results posted yet for this study

Summary

in the last decade, lots of attemps have been done to identify new technologies able to reply the efficacy of gold standard technique for treating BPH, but with a better safety profile. The introduction of laser techniques allowed to reduce complication rates. Among these, considerable importance had Holep and PVP. Aquablation is a recent technique for LUTS treatment. It is minimally invasive, robot-assisted and ultrasound-guided to ablate the prostate in targeted way and in "heat-free" way. It works with high pression water jet. However, in literature informations about disobstructive capacity of minimally invasive techniques, evaluated with invasive urodynamic tests, are low.

The enrolled subjects will undergo surgical treatment with one of the techniques under study: Aquablation, HoLEP or PVP.

Outpatient visits will be performed at 1, 3 and 6 months after the surgical treatment. During the sixth month visit an invasive urodynamic examination will be performed

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

DEVICE

aquablation

minimally invasive, robot-assisted and ultrasound-guided ablation of the prostate in targeted way and in "heat-free" way working by high pression water jet

DEVICE

holep

holmium laser enucleation of prostate

DEVICE

pvp

photoselectivevaporization of prostate

Sponsors & Collaborators

  • Gaetano de Rienzo

    collaborator UNKNOWN

  • Pasquale Ditonno

    collaborator UNKNOWN

  • Francesco Di Modugno

    collaborator UNKNOWN

  • Michele Battaglia

    collaborator UNKNOWN

  • Giuseppe Lucarelli

    collaborator UNKNOWN

  • Marco Spilotros

    collaborator UNKNOWN

  • University of Bari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-10-01
Completion
2019-12-31
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846700 on ClinicalTrials.gov